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Search / Trial NCT04705896

Albumin To Enhance Recovery After Acute Kidney Injury

Launched by OTTAWA HOSPITAL RESEARCH INSTITUTE · Jan 9, 2021

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Albumin Normal Saline Dialysis Intensive Care Unit

ClinConnect Summary

This clinical trial is studying whether a special type of intravenous fluid called hyperoncotic albumin can help critically ill patients with Acute Kidney Injury (AKI) who need renal replacement therapy, like dialysis. The goal is to see if receiving this treatment can lead to more days without needing extra support from medical devices and treatments, specifically looking at the first 28 days after starting the trial. Participants will either receive the albumin or a placebo, which is a normal saline solution, during their treatment sessions.

To be eligible for this trial, participants must be at least 18 years old and have been admitted to a critical care unit for more than 24 hours. They also need to be receiving medications to support their blood pressure or be on mechanical ventilation. Important to note, patients with certain conditions, like end-stage kidney disease or severe liver disease, cannot participate. Those who join can expect to receive either the albumin treatment or the placebo during their renal replacement therapy sessions, and their progress will be monitored to see how well they recover.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Age ≥18 years old;
  • Admission to a critical care unit/intensive care unit (ICU) for \> 24 hours;
  • Receiving vasoactive therapy AND/OR undergoing mechanical ventilation (including non-invasive mechanical ventilation (NIMV));
  • Immediate initiation of RRT for management of AKI is planned OR additional RRT sessions are imminently planned for patients who already received RRT during their ICU admission;
  • Exclusion Criteria:
  • Initiation of RRT for reasons other than AKI (e.g. drug intoxication, hypothermia) ;
  • Known pre-hospitalization end-stage kidney disease;
  • Kidney transplant within the past 365 days;
  • Presence or clinical suspicion of renal obstruction, rapidly progressive glomerulonephritis, vasculitis, thrombotic microangiopathy or acute interstitial nephritis;
  • Advanced cirrhosis (Child Pugh class C \[score 10-15\]), spontaneous bacterial peritonitis or hepatorenal syndrome;
  • Acute peritoneal dialysis used as the initial RRT modality;
  • * Contraindications to albumin:
  • 1. Admitted with traumatic brain injury
  • 2. Increased intra-cranial pressure in those with intra-cranial pressure monitoring
  • 3. Prior history of anaphylaxis to intravenous albumin
  • 4. Contraindication or known objection to albumin/blood product transfusions
  • Already received 2 or more RRT sessions during ICU admission.
  • Limitations of medical therapy precluding RRT/mechanical ventilation/vasoactive medications or plan to transition to palliation

About Ottawa Hospital Research Institute

The Ottawa Hospital Research Institute (OHRI) is a leading academic research institute dedicated to advancing health and healthcare through innovative research and evidence-based practices. Affiliated with The Ottawa Hospital and the University of Ottawa, OHRI fosters a collaborative environment that brings together clinicians, scientists, and trainees to conduct groundbreaking clinical trials and translational research. With a focus on improving patient outcomes, OHRI specializes in a wide range of fields, including cancer, cardiovascular health, and regenerative medicine. The institute is committed to ethical research practices and the dissemination of knowledge to enhance public health and inform healthcare policy.

Locations

Toronto, Ontario, Canada

Ottawa, Ontario, Canada

Ottawa, Ontario, Canada

Kingston, Ontario, Canada

Saskatoon, Saskatchewan, Canada

Hamilton, Ontario, Canada

Halifax, Nova Scotia, Canada

St. Catharines, Ontario, Canada

Montréal, Quebec, Canada

Scarborough, Ontario, Canada

Toronto, Ontario, Canada

Winnipeg, Manitoba, Canada

North York, Ontario, Canada

Whitby, Ontario, Canada

Calgary, Alberta, Canada

Laval, Quebec, Canada

Sherbrooke, Quebec, Canada

Patients applied

0 patients applied

Trial Officials

Edward G Clark, MD MSc FRCPC

Principal Investigator

Ottawa Hospital Research Institute

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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